Last synced on 25 November 2022 at 11:04 pm

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Page Type
Product Code
Definition
Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity.
Physical State
external sound processor, implant (w/ receiver/stimulator and electrode array), programming software, accessories
Technical Method
provide electric stimulation to the mid- to high frequency region of the cochlea via implant and acoustic amplification to the low frequency regions via an external component
Target Area
Head: Ear and Cochlea
Review Panel
Ear, Nose, Throat
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code PGQ to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Page Type
Product Code
Definition
Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity.
Physical State
external sound processor, implant (w/ receiver/stimulator and electrode array), programming software, accessories
Technical Method
provide electric stimulation to the mid- to high frequency region of the cochlea via implant and acoustic amplification to the low frequency regions via an external component
Target Area
Head: Ear and Cochlea
Review Panel
Ear, Nose, Throat
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code PGQ to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.